The present invention relates to an alimentary integrator and a method which are particularly useful in treating or preventing diseases or conditions involving; degenerative forms, weakening of the immune system and stepped-up organic deterioration.
It is a well-known fact that atmospheric and environmental (including electromagnetic) pollution, radiation in general, an irregular diet (with an excess of peroxidated food fats) and food alterations themselves (preservatives, genetically modified substances, etc.), cigarette smoke, prolonged emotional stress and immune and inflammatory reactions are a continual source of free radicals which cause damage to the organism on the cellular level by way of chemical oxidizations of lipids and proteins (oxidated stress). The same angiogenesis, triggering off a hyperoxygenation of the new cytoplasmatic capillary vessels is itself a source of oxidizing stress. The general effects thus produced in the organism are mainly the following: a weakening of the immune system; a stepped-up physiological organic deterioration, and the production of degenerative forms.
In this way biological, physical and chemical alterations are formed that can cause damage to the cellular membrane and to the DNA.
In fact, in the presence of oxidizing stress, the NA+xe2x80x94K+ pump does not perform its task correctly and there occurs an imbalance of the four fundamental cations which are needed to maintain cellular functioning, namely sodium, potassium, calcium and magnesium.
Especially in the presence of degenerative diseases and in particular neoplastic forms. Sodium NA+ (a prevalent cation in extracellular fluids) tends to substitute potassium K+ inside the cell with a resulting serious imbalance find alteration of the NAxe2x80x94K pump.
It is known by Varmus et al. (xe2x80x9cGenes and the Biology of Cancerxe2x80x9dxe2x80x94Scientific American Library, 1993) that the production of degenerative forms is bound to an anomalous cellular behaviour deriving from oxidizing stress that can originate a monotonic polymerization, that is to say uncontrolled proliferation and growth. Although there are different types of degenerative pathologies, the processes that determine them look like the same.
In fact, the oxiding stress causes an imbalance in the concentration of K+ and Na+ cations and a malfunctioning, of the Na+xe2x80x94Ka+ pump and consequent heavy loss of electrolytes not only in the Naxe2x80x94K pump but also in the concentration of the other electrolytes, i.e., calcium and magnesium. Said features were pointed out by Von Euler H. et al. (xe2x80x9cCancer biochemistryxe2x80x94La biochimica dei tumori.xe2x80x9d Cap.II. pp. 78-84 Einaudi -Torino, 1945).
The importance of potassium in the regulation of cellular metabolism was pointed out by Dallaporta B. et al. (xe2x80x9cPotassium leakage during the apoptotic degradation phasexe2x80x9d. The Journal of Immunology, 1998, pp. 5605-5615), by Hughes F. et al. (xe2x80x9cIntracellular K+ Suppresses the Activation of Apoptosis in Lymphocytesxe2x80x9d.xe2x80x94The Journal of Biological Chemistry, Vol. 272, n. 48, 1997, pp. 30567-30576) and by Bortner C. et al. (xe2x80x9cEfflux in the Activation of Apoptosisxe2x80x9dxe2x80x94The Journal of Biological Chemistry, Vol. 272, n. 51, 1997, pp. 32436-32442) relating to the cellular apoptosis and by Moran et al. (xe2x80x9cBiochemistryxe2x80x9d 2nd edition, Prentice Hall, Inc., 1994) relating the rule of co-factor of potassium in the enzymatic catalysis.
U.S. Pat. No. 4,760,138 to So et al. deals with carbonating agents for beverages and uses the calcium ion for medicinal or nutritive supplementation of calcium in the diet.
U.S. Pat. No. 5,424,074 to Koli et al. recognizes the need for potassium in the body, but offsets its deficiency and attendant adverse retention of sodium by a composition combining a magnesium compound with a potassium compound and both an effervescing agent and a neutralizing agent, desirably having ingredients that mask the objectionable taste of potassium.
U.S. Pat. No. 5,626,883 to Paul recognizes the need for ascorbic acid in the body and avoids the initial transitory suppression of human natural killer cells which occurs when ascorbic acid is administered alone, by combining a water soluble form thereof, such as ascorbic acid, niacinamide ascorbate or a metal ion salt of ascorbic acid, with a fat soluble ascorbyl ester and desirably also an ascorbic acid metabolite or precursor.
The aforesaid compound are composed from a very great number of components and their preparation isn""t very simple.
A first aspect of the invention concerns an alimentary integrator which comprises a compound formed from potassium bicarbonate and an anti-oxidant agent comprising ribose, or ribose and I-ascorbic acid.
In one embodiment, the integrator comprises potassium ribosate formed from potassium bicarbonate and ribose, such as two, three, or four parts by weight of potassium bicarbonate and one part by weight of ribose.
The two components of the potassium ribosate may be in associated corresponding single dosage form, combinable at the time of use for obtaining an extemporary solution of the integrator.
In an alternative embodiment, the integrator comprises potassium ribose ascorbate formed from potassium bicarbonate, ribose and I-ascorbic acid, such as two or four parts by weight of potassium bicarbonate, one part by weight of I-ascorbic acid and an amount of ribose corresponding to 0.1-10%, especially about 2%, by weight of the sum of the weights of the potassium bicarbonate and I-ascorbic acid. The three components of the potassium ribose ascorbate may be in associated corresponding single dosage form, combinable at the time of use for obtaining an extemporary solution of the integrator.
Specifically, the alimentary integrator comprises a compound selected from potassium ribosate and potassium ribose ascorbate, such as wherein the potassium ribosate is formed from two to four parts by weight of potassium bicarbonate and one part by weight of ribose, or wherein the potassium ribose ascorbate is formed from two or four parts by weight of potassium bicarbonate, one part by weight of I-ascorbic acid and an amount of ribose corresponding to 0.1-10% by weight of the sum of the weights of the potassium bicarbonate and I-ascorbic acid. The two components of the potassium ribosate, or the three components of the potassium ribose ascorbate, as the case may be, may be in associated corresponding single dosage form, combinable at the time of use for obtaining an extemporary solution of the integrator.
A second aspect of the invention concerns a method of treating or preventing a potassium deficiency based disease or condition in a subject involving weakening of the immune system, stepped-up physiological organic deterioration or the production of cellular degenerative forms, by administering to the subject an effective amount of an alimentary integrator which comprises a compound formed from potassium bicarbonate and an anti-oxidant agent comprising ribose, or ribose and I-ascorbic acid. In particular, the integrator comprises potassium ribosate formed from potassium bicarbonate and ribose, or potassium ribose ascorbate formed from potassium bicarbonate, ribose and I-ascorbic acid.
Specifically, the method comprises administering to the subject an effective amount of an alimentary integrator which comprises a compound selected from potassium ribosate and potassium ribose ascorbate, such as wherein the potassium ribosate is formed from two to four parts by weight of potassium bicarbonate and one.part by weight of ribose, or the potassium ribose ascorbate is formed from two or four part s by weight of potassium bicarbonate, one part by weight of I-ascorbic acid and an amount of ribose corresponding to 0.1-10% by weight of the sum of the weights of the potassium bicarbonate and I-ascorbic acid.
The two components of the potassium ribosate, or the three components of the potassium ribose ascorbate, as the case may be, may be in associated corresponding single dosage form, combinable at the time of use for obtaining an extemporary solution of the integrator.
The alimentary integrator and method of use of the invention serve to supply potassium to the body on a cellular level for treating or preventing an inherently potassium deficiency based disease or condition involving weakening of the immune system, stepped-up physiological organic deterioration or production of cellular degenartive forms. Per the invention, potassium ribosate is usable instead of potassium ribose ascorbate such as where the person treated is allergic to ascorbic acid.
An aim of the present invention is to eliminate the above mentioned drawbacks by providing an alimentary integrator having the characteristics of the claims.
Among the advantages of the present invention is that the integrator is a very powerful anti-oxidizing agent that reduces the effect of free radicals; that it strengthens the activity of the immune system maintaining or revitalizing the concentration of intracellular potassium to the required levels; that it ties together the functional characteristics of its components giving rise to results surprisingly better in respect to the components singularly used, with a synergistic action of the components: that it is completely atoxic (at prescribed doses); that it can be used over a long period of time; that it has a very simple posology. A further advantage is that the integrator is formed from only two components in the embodiment of potassium ribosate, and from only three components in the embodiment of ribose ascorbate.
The present invention points out that potassium may be regarded as a xe2x80x9cco-factor,xe2x80x9d i.e., a substance upon which the catalytic activity of many enzymes depends, potassium being a fundamental element for proteic functions and for regulating cellular activity. In this regard, it is to be pointed out that it has been long known that after an oxidizing stress the final effect of cellular deterioration is a loss of intracellular potassium with the inlet of extracellular potassium into the cytoplasm, and consequent heavy loss of electrolytes not only in the Na-K pump but also in the concentration of the other electrolytes, i.e., calcium and magnesium. The loss of potassium is due to the opening of the pyrrolic rings of proteins, of cytoplasmatic enzymes and of membrane proteins, to which the potassium bonds itself reversibly for carrying out its function. As a result of the above, the cells cannot function in regular manner. Upon cytoplasmatic damage to the pyrrole proteic groups, the consequent lack of potassium not only is accompanied by hypoparathyroidism, vitamin deficiency, nephrosis, renal failure, etc., but also signifies a proliferation of cellular deterioration. In other words, potassium is a critical xe2x80x9cfactorxe2x80x9d for regulating cellular activity.
Per the invention, ribose (potassium ribosate) or combined ribose-ascorbic acid (potassium ribose ascorbate) in the instant alimentary integrator possess not only the known anti-oxidant action of the individual components (ribose and ascorbic acid), but also a heretofore unknown function as potassium xe2x80x9ccarrierxe2x80x9d in the cytoplasm. The instant alimentary integrator thus effects transport of potassium into the cytoplasm of a cell affected by cellular deterioration, damage to pyrrolic groups of angiogenesis phenomena.
This potassium transport is attained by means of the associated ribose (potassium ribosate) or combined ribose-ascorbic acid (potassium ribose ascorbate) of the instant alimentary integrator due to the biochemical-physical features of the ribose and combined ribose-ascorbic acid components. Of course, the molecules of these two components have a cyclic structure of the furanosic type, enabling them to be substituted for damaged protein pyrrolic groups and bind their potassium to such protein, e.g., by salifying the OH groups of these molecules, owing to their particular affinities to the pyrrole NH group, the pyrrole group also being salified by the attendant potassium.